Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 76836-76838 [2013-30185]

Download as PDF 76836 Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices consortium member also receives or has received funding from ANA. • Whether the project provides couples or family counseling activities that are medically-based. • Whether the project originated and was designed by consultants, who have provided a major role for themselves in the performance of the project, and who are not members of the applicant organization, tribe, or village. 3. Scoring Guidance: ANA proposes • Whether the project contains to provide guidance to reviewers to contingent activities that may impede, utilize the table below when allocating or indefinitely delay, the progress of the points for applications in order to project. ensure consistency and equivalence in the scoring among different panels and • Whether the project has the panel reviewers. ANA proposes to add potential to cause unintended harm to the following table to all FY14 FOAs: participants, or that could negatively impact the safety or privacy of Excellent ....................................... 93–100 individuals. Very Good .................................... 86–92 • Whether the project may be used for Good ............................................. 78–85 Fair ................................................ 70–77 the purpose of providing loan capital. Needs Significant Improvement ... 0–69 Federal funds awarded under this FOA may not be used for the purpose of providing loan capital. This restriction L. ANA Internal Review of Proposed is not related to loan capital authorized Projects: ANA proposes to clarify the under Sec. 803A of NAPA [42 U.S.C. language in Section V.2. Review and 2991b-1(a)(1)] for the purpose of the Selection Process of the FOAs to clarify Hawaiian Revolving Loan fund. of the scope of ANA’s discretion to be • Whether the project includes exercised in making funding decisions human subject research as defined at 45 as follows: CFR 45.102 (d) and (f). Based on the ranked order of applications, ANA staff will perform an • Whether the project is duplicative internal review and analysis of the of projects funded by other federal applications ranked highest as a result agencies. of the panel’s review and scoring in Please note: The funding restriction order to determine the application’s applied in prior years’ FOAs on ‘‘Projects consistency with the purposes of NAPA, that seek to revive Native American all relevant statutory and regulatory languages that do not have any living requirements, and the requirements of speakers’’ has been removed from the above the relevant FOA. ANA’s Commissioner list. Projects with this focus are now eligible to receive funding under Language has discretion to make all final funding Preservation and EMI FOAs. and award decisions. In the exercise of such discretion the Commissioner will M. Reporting: ANA proposes to consider: change the frequency of reporting • Whether the project, as determined requirements from quarterly to semibased on ANA’s administrative and annual for the Objective Progress programmatic expertise, does not to Reports (OPR) and Financial Status further the purpose of the funding Reports (FSR). Therefore, grantees will opportunity as described in Section I. be required to submit an OPR and an Funding Opportunity Description. FSR every 6 months instead of every 3 • Whether the project is determined months. Please note that grantees will to be unlikely to be successful or cost still be required to submit a Federal effective based on the application Financial Report—Federal Cash submitted for evaluation in response to Transaction Report SF–425 (FFR–FCTR) Section IV.2. Project Description and to the Division of Payment Management Budget and Budget Justification. (DPM) on a quarterly basis. • Whether the project allows any one Statutory Authority: This notice for public community, or region, to receive a comment is required by Section 814 of the disproportionate share of the funds Native American Programs Act of 1974 available for award. (NAPA), as amended. • Whether the projects is essentially Lillian A. Sparks Robinson, identical or similar in whole or in part Commissioner, Administration for Native to previously funded projects proposed American. by the same applicant or activities or [FR Doc. 2013–30192 Filed 12–18–13; 8:45 am] projects proposed by a consortium that duplicate activities for which any BILLING CODE 4184–34–P emcdonald on DSK67QTVN1PROD with NOTICES important to project monitoring and success. For all FY14 FOAs, ANA proposes to use the following criteria values: Need for Assistance—10 points; Outcomes Expected—25 points; Project Approach—30 points; Objective Work Plan—25 points Budget and Budget Justification—10 points VerDate Mar<15>2010 16:41 Dec 18, 2013 Jkt 232001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1619] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of FDA’s regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either electronic or written comments on the collection of information by February 18, 2014. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or SUMMARY: E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements—21 CFR Part 111 (OMB Control Number 0910–0606)—Extension On October 25, 1994, the Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 103–417) was signed into law. DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section 402(g)(2) of the FD&C Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices for dietary supplements. Section 402(g) of the FD&C Act also stipulates that such regulations will be modeled after CGMP regulations for food and may not impose standards for which there are no current, and generally available, analytical methodology. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if ‘‘it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.’’ Under section 701(a) of the FD&C Act (21 U.S.C. 371), FDA may issue regulations necessary for the efficient enforcement of the FD&C Act. In the Federal Register of June 25, 2007 (72 FR 34752) (the June 25, 2007, final VerDate Mar<15>2010 16:41 Dec 18, 2013 Jkt 232001 rule), FDA published a final rule that established, in part 111 (21 CFR part 111), the minimum CGMP necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Records are an indispensable component of CGMP. The records required by FDA’s regulations in part 111 provide the foundation for the planning, control, and improvement processes that constitute a quality control system. Implementation of these processes in a manufacturing operation serves as the backbone to CGMP. The records show what is to be manufactured; what was, in fact, manufactured; and whether the controls that the manufacturer put in place to ensure the identity, purity, strength, and composition and limits on contaminants and to prevent adulteration were effective. Further, records will show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective. In addition, by establishing recordkeeping requirements, FDA can ensure that industry follows CGMP during manufacturing, packaging, labeling, or holding operations. The regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling or holding operations. The recordkeeping requirements of the regulations include establishing written procedures and maintaining records pertaining to: (1) Personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning, and sanitizing equipment and utensils and other contact surfaces; (6) water used that may become a component of the dietary supplement; (7) production and process controls; (8) quality control; (9) components, packaging, labels and product received for packaging and labeling; (10) master manufacturing and batch production; (11) laboratory operations; (12) manufacturing operations; (13) packaging and labeling operations; (14) holding and distributing operations; (15) returned dietary supplements; and (16) product complaints. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 76837 Description of Respondents: Manufacturers, dietary supplement manufacturers, packagers and repackagers, labelers and re-labelers, holders, distributors, warehousers, exporters, importers, large businesses, and small businesses engaged in the dietary supplement industry. The recordkeeping requirements of the regulations in part 111 are set forth in each subpart. In Table 1 of this document we list the annual burdens associated with recordkeeping, as described in the June 25, 2007, final rule. For some provisions listed in Table 1, we did not estimate the number of records per recordkeeper because recordkeeping occasions consist of frequent brief entries of dates, temperatures, monitoring results, or documentation that specific actions were taken. Information might be recorded a few times a day, week, or month. When the records burden involves frequent brief entries, we entered 1 as the default for the number of records per recordkeeper. For example, many of the records listed under § 111.35 in Table 1, such as § 111.35(b)(2) (documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment), involve many short sporadic entries over the course of the year, varying across equipment and plants in the industry. We did not attempt to estimate the actual number of recordkeeping occasions for these provisions, but instead entered an estimate of the average number of hours per year. We entered the default value of 1 as the number of records per recordkeeper for these and similar provisions. For § 111.35, the entry for number of records is 1 as a default representing a large number of brief recordkeeping occasions. In many rows of Table 1 of this document, we list a burden under a single provision that covers the written procedures or records described in several provisions. For example, the burden of the batch production records listed in Table 1 under § 111.260 includes the burden for records listed under § 111.255 because the batch production records must include those records. The number of records for batch production records (and other records kept on a batch basis in Table 1 of this document) equals the annual number of batches. The estimated burden for records kept by batch includes both records kept for every batch and records kept for some but not all batches. We use the annual number of batches as the number of records that will not necessarily be kept for every batch, such E:\FR\FM\19DEN1.SGM 19DEN1 76838 Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices as test results or material review and disposition records, because such records are part of records, if they are necessary, that will be kept for every batch. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section 111.14, records of personnel practices, including documentation of training ......................................................... 111.23, records of physical plant sanitation practices, including pest control and water quality ............................. 111.35, records of equipment and utensils calibration and sanitation practices ........................................................... 111.95, records of production and process control systems 111.140, records that quality control personnel must make and keep ........................................................................... 111.180, records associated with components, packaging, labels, and product received for packaging and labeling as a dietary supplement ................................................... 111.210, requirements for what the master manufacturing record must include .......................................................... 111.260, requirements for what the batch record must include ................................................................................. 111.325, records that quality control personnel must make and keep for laboratory operations .................................. 111.375, records of the written procedures established for manufacturing operations ................................................. 111.430, records of the written procedures for packaging and labeling operations .................................................... 111.475, records of product distribution and procedures for holding and distributing operations ............................. 111.535, records for returned dietary supplements ............ 111.570, records regarding product complaints .................. Total .............................................................................. emcdonald on DSK67QTVN1PROD with NOTICES 1 There Number of records per recordkeeper Total annual records Avg. burden per recordkeeping Total hours 15,000 4 60,000 1 60,000 15,000 1 15,000 0.2 3,000 400 250 1 1 400 250 12.5 45 5,000 11,250 240 1163 279,120 1 279,120 240 1163 279,120 1 279,120 240 1 240 2.5 600 145 1408 204,160 1 204,160 120 1 120 15 1,800 260 1 260 2 520 50 1 50 12.6 630 15,000 110 240 1 4 600 15,000 440 144,000 0.4 13.5 0.5 6,000 5,940 72,000 ........................ ........................ ........................ ........................ 929,140 are no capital costs or operating and maintenance costs associated with this collection of information. The average burden per recordkeeping estimates in Table 1 of this document are based on those in the June 25, 2007, final rule, which were based on our institutional experience with other CGMP requirements and on data provided by Research Triangle Institute in the ‘‘Survey of Manufacturing Practices in the Dietary Supplement Industry’’ cited in that rule. The estimates in Table 1 of the number of firms affected by each provision of part 111 are based on the percentage of manufacturers, packagers, labelers, holders, distributors, and warehousers that reported in the survey that they have not established written SOPs or do not maintain records that were later required by the June 25, 2007, final rule. Because we do not have survey results for general warehouses, we entered the approximate number of facilities in that category for those provisions covering general facilities. For the dietary supplement industry, the survey estimated that 1,460 firms would be covered by the final rule, including manufacturers, packagers, labelers, holders, distributors, and warehousers. The time estimates include the burden involved in documenting that certain VerDate Mar<15>2010 16:41 Dec 18, 2013 Jkt 232001 requirements are performed and in recordkeeping. We used an estimated annual batch production of 1,408 batches per year to estimate the burden of requirements that are related to the number of batches produced annually, such as § 111.260, ‘‘What must the batch production record include?’’ The estimate of 1,408 batches per year is near the midpoint of the number of annual batches reported by survey firms. The length of time that CGMP records must be maintained is set forth in § 111.605. Table 1 of this document reflects the estimated burdens for written procedures, record maintenance, periodically reviewing records to determine if they may be discarded, and for any associated documentation for that activity for records that are required under part 111. We have not included a separate estimate of burden for those sections that require maintaining records in accordance with § 111.605, but have included those burdens under specific provisions for keeping records. For example, § 111.255(a) requires that the batch production records be prepared every time a batch is manufactured, and § 111.255(d) requires PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 that batch production records be kept in accordance with § 111.605. The estimated burdens for both § 111.255(a) and (d) are included under § 111.260 (what the batch record must include). Dated: December 13, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–30185 Filed 12–18–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1588] Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, Exemptions From Substantial Equivalence Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the SUMMARY: E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76836-76838]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30185]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1619]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Current Good Manufacturing Practice in Manufacturing, 
Packaging, Labeling, or Holding Operations for Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice invites comments on the information collection 
provisions of FDA's regulations regarding current good manufacturing 
practice (CGMP) for dietary supplements.

DATES: Submit either electronic or written comments on the collection 
of information by February 18, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or

[[Page 76837]]

provide information to a third party. Section 3506(c)(2)(A) of the PRA 
(44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information, including each proposed extension of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Current Good Manufacturing Practice in Manufacturing, Packaging, 
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 
111 (OMB Control Number 0910-0606)--Extension

    On October 25, 1994, the Dietary Supplement Health and Education 
Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other 
things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section 
402(g)(2) of the FD&C Act provides, in part, that the Secretary of 
Health and Human Services may, by regulation, prescribe good 
manufacturing practices for dietary supplements. Section 402(g) of the 
FD&C Act also stipulates that such regulations will be modeled after 
CGMP regulations for food and may not impose standards for which there 
are no current, and generally available, analytical methodology. 
Section 402(g)(1) of the FD&C Act states that a dietary supplement is 
adulterated if ``it has been prepared, packed, or held under conditions 
that do not meet current good manufacturing practice regulations.'' 
Under section 701(a) of the FD&C Act (21 U.S.C. 371), FDA may issue 
regulations necessary for the efficient enforcement of the FD&C Act. In 
the Federal Register of June 25, 2007 (72 FR 34752) (the June 25, 2007, 
final rule), FDA published a final rule that established, in part 111 
(21 CFR part 111), the minimum CGMP necessary for activities related to 
manufacturing, packaging, labeling, or holding dietary supplements to 
ensure the quality of the dietary supplement.
    Records are an indispensable component of CGMP. The records 
required by FDA's regulations in part 111 provide the foundation for 
the planning, control, and improvement processes that constitute a 
quality control system. Implementation of these processes in a 
manufacturing operation serves as the backbone to CGMP. The records 
show what is to be manufactured; what was, in fact, manufactured; and 
whether the controls that the manufacturer put in place to ensure the 
identity, purity, strength, and composition and limits on contaminants 
and to prevent adulteration were effective. Further, records will show 
whether and what deviations from control processes occurred, facilitate 
evaluation and corrective action concerning these deviations 
(including, where necessary, whether associated batches of product 
should be recalled from the marketplace), and enable a manufacturer to 
assure that the corrective action was effective. In addition, by 
establishing recordkeeping requirements, FDA can ensure that industry 
follows CGMP during manufacturing, packaging, labeling, or holding 
operations. The regulations in part 111 establish the minimum 
manufacturing practices necessary to ensure that dietary supplements 
are manufactured, packaged, labeled, or held in a manner that will 
ensure the quality of the dietary supplements during manufacturing, 
packaging, labeling or holding operations.
    The recordkeeping requirements of the regulations include 
establishing written procedures and maintaining records pertaining to: 
(1) Personnel; (2) sanitation; (3) calibration of instruments and 
controls; (4) calibration, inspection, or checks of automated, 
mechanical, or electronic equipment; (5) maintaining, cleaning, and 
sanitizing equipment and utensils and other contact surfaces; (6) water 
used that may become a component of the dietary supplement; (7) 
production and process controls; (8) quality control; (9) components, 
packaging, labels and product received for packaging and labeling; (10) 
master manufacturing and batch production; (11) laboratory operations; 
(12) manufacturing operations; (13) packaging and labeling operations; 
(14) holding and distributing operations; (15) returned dietary 
supplements; and (16) product complaints.
    Description of Respondents: Manufacturers, dietary supplement 
manufacturers, packagers and repackagers, labelers and re-labelers, 
holders, distributors, warehousers, exporters, importers, large 
businesses, and small businesses engaged in the dietary supplement 
industry.
    The recordkeeping requirements of the regulations in part 111 are 
set forth in each subpart. In Table 1 of this document we list the 
annual burdens associated with recordkeeping, as described in the June 
25, 2007, final rule. For some provisions listed in Table 1, we did not 
estimate the number of records per recordkeeper because recordkeeping 
occasions consist of frequent brief entries of dates, temperatures, 
monitoring results, or documentation that specific actions were taken. 
Information might be recorded a few times a day, week, or month. When 
the records burden involves frequent brief entries, we entered 1 as the 
default for the number of records per recordkeeper. For example, many 
of the records listed under Sec.  111.35 in Table 1, such as Sec.  
111.35(b)(2) (documentation, in individual equipment logs, of the date 
of the use, maintenance, cleaning, and sanitizing of equipment), 
involve many short sporadic entries over the course of the year, 
varying across equipment and plants in the industry. We did not attempt 
to estimate the actual number of recordkeeping occasions for these 
provisions, but instead entered an estimate of the average number of 
hours per year. We entered the default value of 1 as the number of 
records per recordkeeper for these and similar provisions. For Sec.  
111.35, the entry for number of records is 1 as a default representing 
a large number of brief recordkeeping occasions.
    In many rows of Table 1 of this document, we list a burden under a 
single provision that covers the written procedures or records 
described in several provisions. For example, the burden of the batch 
production records listed in Table 1 under Sec.  111.260 includes the 
burden for records listed under Sec.  111.255 because the batch 
production records must include those records.
    The number of records for batch production records (and other 
records kept on a batch basis in Table 1 of this document) equals the 
annual number of batches. The estimated burden for records kept by 
batch includes both records kept for every batch and records kept for 
some but not all batches. We use the annual number of batches as the 
number of records that will not necessarily be kept for every batch, 
such

[[Page 76838]]

as test results or material review and disposition records, because 
such records are part of records, if they are necessary, that will be 
kept for every batch.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                      Avg. burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
111.14, records of personnel              15,000               4          60,000               1          60,000
 practices, including
 documentation of training......
111.23, records of physical               15,000               1          15,000             0.2           3,000
 plant sanitation practices,
 including pest control and
 water quality..................
111.35, records of equipment and             400               1             400            12.5           5,000
 utensils calibration and
 sanitation practices...........
111.95, records of production                250               1             250              45          11,250
 and process control systems....
111.140, records that quality                240            1163         279,120               1         279,120
 control personnel must make and
 keep...........................
111.180, records associated with             240            1163         279,120               1         279,120
 components, packaging, labels,
 and product received for
 packaging and labeling as a
 dietary supplement.............
111.210, requirements for what               240               1             240             2.5             600
 the master manufacturing record
 must include...................
111.260, requirements for what               145            1408         204,160               1         204,160
 the batch record must include..
111.325, records that quality                120               1             120              15           1,800
 control personnel must make and
 keep for laboratory operations.
111.375, records of the written              260               1             260               2             520
 procedures established for
 manufacturing operations.......
111.430, records of the written               50               1              50            12.6             630
 procedures for packaging and
 labeling operations............
111.475, records of product               15,000               1          15,000             0.4           6,000
 distribution and procedures for
 holding and distributing
 operations.....................
111.535, records for returned                110               4             440            13.5           5,940
 dietary supplements............
111.570, records regarding                   240             600         144,000             0.5          72,000
 product complaints.............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         929,140
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The average burden per recordkeeping estimates in Table 1 of this 
document are based on those in the June 25, 2007, final rule, which 
were based on our institutional experience with other CGMP requirements 
and on data provided by Research Triangle Institute in the ``Survey of 
Manufacturing Practices in the Dietary Supplement Industry'' cited in 
that rule.
    The estimates in Table 1 of the number of firms affected by each 
provision of part 111 are based on the percentage of manufacturers, 
packagers, labelers, holders, distributors, and warehousers that 
reported in the survey that they have not established written SOPs or 
do not maintain records that were later required by the June 25, 2007, 
final rule. Because we do not have survey results for general 
warehouses, we entered the approximate number of facilities in that 
category for those provisions covering general facilities. For the 
dietary supplement industry, the survey estimated that 1,460 firms 
would be covered by the final rule, including manufacturers, packagers, 
labelers, holders, distributors, and warehousers. The time estimates 
include the burden involved in documenting that certain requirements 
are performed and in recordkeeping. We used an estimated annual batch 
production of 1,408 batches per year to estimate the burden of 
requirements that are related to the number of batches produced 
annually, such as Sec.  111.260, ``What must the batch production 
record include?'' The estimate of 1,408 batches per year is near the 
midpoint of the number of annual batches reported by survey firms.
    The length of time that CGMP records must be maintained is set 
forth in Sec.  111.605. Table 1 of this document reflects the estimated 
burdens for written procedures, record maintenance, periodically 
reviewing records to determine if they may be discarded, and for any 
associated documentation for that activity for records that are 
required under part 111. We have not included a separate estimate of 
burden for those sections that require maintaining records in 
accordance with Sec.  111.605, but have included those burdens under 
specific provisions for keeping records. For example, Sec.  111.255(a) 
requires that the batch production records be prepared every time a 
batch is manufactured, and Sec.  111.255(d) requires that batch 
production records be kept in accordance with Sec.  111.605. The 
estimated burdens for both Sec.  111.255(a) and (d) are included under 
Sec.  111.260 (what the batch record must include).

    Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30185 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P